Surgical Treatment of Female Stress Urinary Incontinence: AUA/SUFU Guideline
TL;DR: The surgical options for the treatment of stress urinary incontinence continue to evolve; as such, this guideline and the associated algorithm aim to outline the currently available treatment techniques as well as the data associated with each treatment.
About: This article is published in The Journal of Urology.The article was published on 2017-10-01. It has received 241 citations till now. The article focuses on the topics: Urinary incontinence & Overactive bladder.
Citations
More filters
TL;DR: Clinicians should prioritize urinary incontinence detection, identify and treat modifiable factors, incorporate patient preference into evaluation and treatment, initiate conservative and medical therapy, and refer to specialists when underlying pathology is identified or conservative measures are ineffective.
Abstract: Importance Urinary incontinence, the involuntary loss of urine, is a common health condition that may decrease quality of life. Ten to twenty percent of women and up to 77% of women residing in nursing homes have urinary incontinence, yet only 25% seek or receive treatment. Observations This review summarizes the evaluation and therapeutic options for women affected by urinary incontinence. The initial assessment should focus on understanding the effect of incontinence on quality of life, the patient’s goals and preferences for treatment, the results of previous treatments, and the presence of concomitant conditions, such as advanced pelvic organ prolapse, that may require referral. Infection and hematuria need to be ruled out. In the absence of urinary infection or serious underlying pathology (such as cancer or serious neurologic disease) associated with urinary incontinence, the clinician should initiate unsupervised pelvic muscle exercises and lifestyle modifications appropriate to the patient to reduce her symptoms. These recommendations can include weight loss, adequate hydration, avoidance of excessive fluids, and regular voiding intervals that reduce urgency incontinence episodes. Urgency incontinence medications, with timely reassessment of symptoms, can be started without extensive evaluation. Specialist treatments for urgency incontinence include onabotulinumtoxinA and percutaneous or implanted neuromodulators. Stress incontinence surgery, the midurethral sling, is associated with symptom improvement in 48% to 90% of women and has low rates of mesh complications ( Conclusions and Relevance Urinary incontinence is common in women, although few seek care despite many effective treatment options. Clinicians should prioritize urinary incontinence detection, identify and treat modifiable factors, incorporate patient preference into evaluation and treatment, initiate conservative and medical therapy, and refer to specialists when underlying pathology is identified or conservative measures are ineffective.
248 citations
TL;DR: Treatment with electroacupuncture involving the lumbosacral region, compared with sham electroac acupuncture, resulted in less urine leakage after 6 weeks, and further research is needed to understand long-term efficacy and the mechanism of action of this intervention.
Abstract: Importance Electroacupuncture involving the lumbosacral region may be effective for women with stress urinary incontinence (SUI), but evidence is limited. Objective To assess the effect of electroacupuncture vs sham electroacupuncture for women with SUI. Design, Setting, and Participants Multicenter, randomized clinical trial conducted at 12 hospitals in China and enrolling 504 women with SUI between October 2013 and May 2015, with data collection completed in December 2015. Interventions Participants were randomly assigned (1:1) to receive 18 sessions (over 6 weeks) of electroacupuncture involving the lumbosacral region (n = 252) or sham electroacupuncture (n = 252) with no skin penetration on sham acupoints. Main Outcomes and Measures The primary outcome was change from baseline to week 6 in the amount of urine leakage, measured by the 1-hour pad test. Secondary outcomes included mean 72-hour urinary incontinence episodes measured by a 72-hour bladder diary (72-hour incontinence episodes). Results Among the 504 randomized participants (mean [SD] age, 55.3 [8.4] years), 482 completed the study. Mean urine leakage at baseline was 18.4 g for the electroacupuncture group and 19.1 g for the sham electroacupuncture group. Mean 72-hour incontinence episodes were 7.9 for the electroacupuncture group and 7.7 for the sham electroacupuncture group. At week 6, the electroacupuncture group had greater decrease in mean urine leakage (−9.9 g) than the sham electroacupuncture group (−2.6 g) with a mean difference of 7.4 g (95% CI, 4.8 to 10.0; P P = .01), 2.0 episodes in weeks 15 to 18 (95% CI, 1.3-2.7; P P Conclusions and Relevance Among women with stress urinary incontinence, treatment with electroacupuncture involving the lumbosacral region, compared with sham electroacupuncture, resulted in less urine leakage after 6 weeks. Further research is needed to understand long-term efficacy and the mechanism of action of this intervention. Trial Registration clinicaltrials.gov Identifier:NCT01784172.
224 citations
Brown University1, RMIT University2, University of Pennsylvania3, University of Alabama at Birmingham4, University of California, San Diego5, University of Pittsburgh6, Duke University7, University of New Mexico8, Cleveland Clinic9, Kaiser Permanente10, National Institutes of Health11, Research Triangle Park12
TL;DR: Among women with mixed urinary incontinence, behavioral and pelvic floor muscle therapy combined with midurethral sling surgery compared with surgery alone resulted in a small statistically significant difference in urinary incentinence symptoms at 12 months that did not meet the prespecified threshold for clinical importance.
Abstract: Importance Mixed urinary incontinence, including both stress and urgency incontinence, has adverse effects on a woman’s quality of life. Studies evaluating treatments to simultaneously improve both components are lacking. Objective To determine whether combining behavioral and pelvic floor muscle therapy with midurethral sling is more effective than sling alone for improving mixed urinary incontinence symptoms. Design, Setting, and Participants Randomized clinical trial involving women 21 years or older with moderate or severe stress and urgency urinary incontinence symptoms for at least 3 months, and at least 1 stress and 1 urgency incontinence episode on a 3-day bladder diary. The trial was conducted across 9 sites in the United States, enrollment between October 2013 and April 2016; final follow-up October 2017. Interventions Behavioral and pelvic floor muscle therapy (included 1 preoperative and 5 postoperative sessions through 6 months) combined with midurethral sling (n = 209) vs sling alone (n = 207). Main Outcomes and Measures The primary outcome was change between baseline and 12 months in mixed incontinence symptoms measured by the Urogenital Distress Inventory (UDI) long form; range, 0 to 300 points; minimal clinically important difference, 35 points, with higher scores indicating worse symptoms. Results Among 480 women randomized (mean [SD] age, 54.0 years [10.7]), 464 were eligible and 416 (86.7%) had postbaseline outcome data and were included in primary analyses. The UDI score in the combined group significantly decreased from 178.0 points at baseline to 30.7 points at 12 months, adjusted mean change −128.1 points (95% CI, −146.5 to −109.8). The UDI score in the sling-only group significantly decreased from 176.8 to 34.5 points, adjusted mean change −114.7 points (95% CI, −133.3 to −96.2). The model-estimated between-group difference (−13.4 points; 95% CI, −25.9 to −1.0;P = .04) did not meet the minimal clinically important difference threshold. Related and unrelated serious adverse events occurred in 10.2% of the participants (8.7% combined and 11.8% sling only). Conclusions and Relevance Among women with mixed urinary incontinence, behavioral and pelvic floor muscle therapy combined with midurethral sling surgery compared with surgery alone resulted in a small statistically significant difference in urinary incontinence symptoms at 12 months that did not meet the prespecified threshold for clinical importance. Trial Registration ClinicalTrials.gov Identifier:NCT01959347
49 citations
TL;DR: An educational module is developed, comprising a Powerpoint™ presentation and evidence base manuscript, to instruct on the performance, interpretation, and reporting of the CST in a standardized manner: the ICS‐Uniform Cough Stress Test (ICS‐UCST).
Abstract: Introduction A cough stress test (CST) is recommended in the evaluation of the uncomplicated female patient with the complaint of stress urinary incontinence (SUI) to identify the sign of SUI, and is often used as an outcome measure following SUI treatment. However, there has been no standardization of the performance or reporting of CST. A working group of the International Continence Society (ICS) has developed an educational module, comprising a Powerpoint™ presentation and evidence base manuscript, to instruct on the performance, interpretation, and reporting of the CST in a standardized manner: the ICS-Uniform Cough Stress Test (ICS-UCST). Methods The working group performed a PUBMED literature search of articles (observational/experimental and reviews) published prior to 2017 that mentioned a CST. The evidence base examined various variables in performing a CST as well as sensitivity/specificity and positive/negative predictive values of CST. Results The variables involved in performing/interpreting an ICS-UCST include: patient positioning, degree of bladder filling, number, and forcefulness of coughs, and method of SUI detection. For the ICS-UCST it is recommended that the patient be in a supine/lithotomy position with 200-400 mL of fluid in the bladder. She coughs forcefully 1-4 times and the examiner directly visualizes the urethral meatus for the presence of leakage. Leakage of fluid from the urethral meatus coincident with/simultaneous to the cough(s) is considered a positive test. Conclusion This module provides instructions to educate a uniform CST (the ICS-UCST), with the aim of improving the clinical practice of cough stress testing in female patients with urinary incontinence.
40 citations
Cites background from "Surgical Treatment of Female Stress..."
...2,6–8 Although the European Association of Urology guideline is brief about this test, the recent American Urological Association guideline considers it a sine- qua-non for the diagnosis of SUI.(9,10) Based on their review, the FIGO working group recommended all patients being evaluated for SUI-S should have a CST (Grade A)(8) and in a research context, CST has been the most commonly used measure for evaluating the outcome of SUI surgery....
[...]
...2018;37:1849–1855. wileyonlinelibrary.com/journal/nau © 2018 Wiley Periodicals, Inc. | 1849 and the visualization of urine loss synchronous with the cough confirms the presence of stress urinary incontinence (SUI).1 CST is used to objectively make the diagnosis of SUI2 and assess the outcome of treatment for SUI.3,4 Its use in the evaluation of UI (when symptoms of SUI are expressed; the SUI syndrome: SUI-S5) has been endorsed by several societies including the French College of Gynecologists and Obstetricians; International Federation of Gynecology and Obstetrics (FIGO); International Urogynecological Association (IUGA), and American College of Obstetricians and Gynecologists.2,6–8 Although the European Association of Urology guideline is brief about this test, the recent American Urological Association guideline considers it a sine- qua-non for the diagnosis of SUI.9,10 Based on their review, the FIGO working group recommended all patients being evaluated for SUI-S should have a CST (Grade A)8 and in a research context, CST has been the most commonly used measure for evaluating the outcome of SUI surgery.3,4 Despite the support for the CST, standardization of how to perform a CST does not exist....
[...]
...There is general consensus that the CST in combination with the SUI-S is reliable in confirming that the pathophysiology of the UI is SUI.11–18 In a review of the literature to determine the predictive value of the clinical evaluation of SUI (history, physical exam with CST) using multichannel UDS as the comparator, it was found that for the diagnosis of genuine SUI, the CST alone had sensitivity (sens...
[...]
...As previously noted, a negative CST in the supine/lithotomy position does not necessarily rule out the presence of SUI....
[...]
...In the supine position (using pads to measure the leakage), it was noted that only 49% of women leaked during the cough stress test (when floor and trampoline jumping were used as the comparator).19 In addition, CST was negative when done in a semi-supine position in 14% of patients who complain of SUI in another study on the effects of a UDS catheter on the diagnosis of SUI.20 Furthermore, it has been noted that during LPP testing (done during CMG with a catheter in place), both Valsalva LPP and CLPP are significantly lower when the patient is standing versus supine.21 However, probably the most convenient time to do a CST is when the patient is undergoing a vaginal exam in the supine/lithotomy position (legs either in stirrups or abducted in a “frog-leg” position), when one assesses vaginal anatomy and pelvic floor function....
[...]
TL;DR: Although the primary efficacy finding was inconclusive, these results inform future trial design of AMDC-USR to identify clinically meaningful efficacy endpoints based on IEF reduction, understanding of placebo response rate, and refinement of subject selection criteria to more appropriately align with AMDC -USR’s proposed mechanism of action.
Abstract: The purpose of the study was to assess safety and efficacy of autologous muscle derived cells for urinary sphincter repair (AMDC-USR) in female subjects with predominant stress urinary incontinence. A randomized, double-blind, multicenter trial examined intra-sphincteric injection of 150 × 106 AMDC-USR versus placebo in female subjects with stress or stress predominant, mixed urinary incontinence. AMDC-USR products were generated from vastus lateralis needle biopsies. Subjects were randomized 2:1 to receive AMDC-USR or placebo and 1:1 to receive 1 or 2 treatments (6 months after the first). Primary outcome was composite of ≥ 50% reduction in stress incontinence episode frequency (IEF), 24-h or in-office pad weight tests at 12 months. Other outcome data included validated subject-recorded questionnaires. Subjects randomized to placebo could elect to receive open-label AMDC-USR treatment after 12 months. Subject follow-up was up to 2 years. AMDC-USR was safe and well-tolerated with no product-related serious adverse events or discontinuations due to adverse events. Interim analysis revealed an unexpectedly high placebo response rate (90%) using the composite primary outcome which prevented assessment of treatment effect as designed and thus enrollment was halted at 61% of planned subjects. Post hoc analyses suggested that more stringent endpoints lowered placebo response rates and revealed a possible treatment effect. Although the primary efficacy finding was inconclusive, these results inform future trial design of AMDC-USR to identify clinically meaningful efficacy endpoints based on IEF reduction, understanding of placebo response rate, and refinement of subject selection criteria to more appropriately align with AMDC-USR’s proposed mechanism of action.
38 citations
References
More filters
TL;DR: The Delphi technique is well suited as a method for consensus-building by using a series of questionnaires delivered using multiple iterations to collect data from a panel of selected subjects.
Abstract: The Delphi technique is a widely used and accepted method for gathering data from respondents within their domain of expertise. The technique is designed as a group communication process which aims to achieve a convergence of opinion on a specific real-world issue. The Delphi process has been used in various fields of study such as program planning, needs assessment, policy determination, and resource utilization to develop a full range of alternatives, explore or expose underlying assumptions, as well as correlate judgments on a topic spanning a wide range of disciplines. The Delphi technique is well suited as a method for consensus-building by using a series of questionnaires delivered using multiple iterations to collect data from a panel of selected subjects. Subject selection, time frames for conducting and completing a study, the possibility of low response rates, and unintentionally guiding feedback from the respondent group are areas which should be considered when designing and implementing a Delphi study.
3,704 citations
"Surgical Treatment of Female Stress..." refers methods in this paper
...Where gaps in the evidence existed, the Panel provides guidance in the form of Clinical Principles or Expert Opinion w ith consensus achieved using a modified Delphi technique if differences of opinion emerged.(5) A Clinical Principle is a statement for which there may or may not be evidence in the medical literature and that is widely agreed upon by urologists or other clinicians....
[...]
TL;DR: The refined Quality In Prognosis Studies tool is described, which includes questions related to these areas that can inform judgments of risk of bias in prognostic research.
Abstract: Previous work has identified 6 important areas to consider when evaluating validity and bias in studies of prognostic factors: participation, attrition, prognostic factor measurement, confounding measurement and account, outcome measurement, and analysis and reporting. This article describes the Quality In Prognosis Studies tool, which includes questions related to these areas that can inform judgments of risk of bias in prognostic research.A working group comprising epidemiologists, statisticians, and clinicians developed the tool as they considered prognosis studies of low back pain. Forty-three groups reviewing studies addressing prognosis in other topic areas used the tool and provided feedback. Most reviewers (74%) reported that reaching consensus on judgments was easy. Median completion time per study was 20 minutes; interrater agreement (κ statistic) reported by 9 review teams varied from 0.56 to 0.82 (median, 0.75). Some reviewers reported challenges making judgments across prompting items, which were addressed by providing comprehensive guidance and examples. The refined Quality In Prognosis Studies tool may be useful to assess the risk of bias in studies of prognostic factors.
1,997 citations
"Surgical Treatment of Female Stress..." refers methods in this paper
...used the Quality in Prognostic Studies (QUIPS) tool.(3)...
[...]
TL;DR: To develop and evaluate the International Consultation on Incontinence Questionnaire (ICIQ), a new questionnaire to assess urinary incontinence and its impact on quality of life (QoL).
Abstract: Aims: To develop and evaluate the International Consultation on Incontinence Questionnaire (ICIQ), a new questionnaire to assess urinary incontinence and its impact on quality of life (QoL). Methods: A developmental version of the questionnaire was produced following systematic literature review and views of an expert committee and patients. Several studies were undertaken to evaluate the psychometric properties of the questionnaire, including content, construct and convergent validity, reliability and sensitivity to change. Results: The ICIQ was easily completed, with low levels of missing data (mean 1.6%). It was able to discriminate among diierent groups of individuals, indicating good construct validity. Convergent validity was acceptable, with most items demonstrating ‘moderate’ to ‘strong’ agreement with other questionnaires. Reliability was good, with ‘moderate’ to ‘very good’ stability in test-retest analysis and a Cronbach’s alpha of 0.95. Items identi¢ed statistically signi¢cant reductions in symptoms from baseline following surgical and conservative treatment. Item reduction techniques were used to determine the ¢nal version and scoring scheme, which also demonstrated good psychometric properties. Conclusions: The ¢nal ICIQ comprises three scored items and an unscored self-diagnostic item. It allows the assessment of the prevalence, frequency, and perceived cause of urinary incontinence, and its impact on everyday life. The ICIQ is a brief and robust questionnaire that will be of use in outcomes and epidemiological research as well as routine clinical practice. Neurourol. Urodynam. 23:322 ^330, 2004. 2004 Wiley-Liss, Inc.
1,543 citations
TL;DR: The short form versions of the Incontinence Impact Questionnaire (IIQ) and the Urogenital Distress Inventory (UDI) may be more useful than the long form versions in many clinical and research applications.
Abstract: This article describes short form versions of the Incontinence Impact Questionnaire (IIQ) and the Urogenital Distress Inventory (UDI). These instruments assess life impact and symptom distress, respectively, of urinary incontinence and related conditions for women. All subsets regression analysis was used to find item subsets that best approximated scores of the long form versions. The approach succeeded in reducing the 30-item IIQ and the 19-item UDI to 7- and 6-item short forms, respectively. The short form versions may be more useful than the long form versions in many clinical and research applications.
1,306 citations
University of Alabama at Birmingham1, University of California, San Diego2, University of Pittsburgh3, Loyola University Chicago4, University of Utah5, Beaumont Hospital6, University of Texas at San Antonio7, University of Maryland, Baltimore8, University of Texas Southwestern Medical Center9, Kaiser Permanente10, National Institutes of Health11, Dartmouth College12
TL;DR: The 12-month rates of objectively assessed success of treatment for stress incontinence with the retropubic and transobturator approaches met the prespecified criteria for equivalence; the rates of subjectively assessed success were similar between groups but did not meet the criteria for interchange.
Abstract: Background Midurethral slings are increasingly used for the treatment of stress incontinence, but there are limited data comparing types of slings and associated complications. Methods We performed a multicenter, randomized equivalence trial comparing outcomes with retropubic and transobturator midurethral slings in women with stress incontinence. The primary outcome was treatment success at 12 months according to both objective criteria (a negative stress test, a negative pad test, and no retreatment) and subjective criteria (self-reported absence of symptoms, no leakage episodes recorded, and no retreatment). The predetermined equivalence margin was ±12 percentage points. Results A total of 597 women were randomly assigned to a study group; 565 (94.6%) completed the 12-month assessment. The rates of objectively assessed treatment success were 80.8% in the retropubic-sling group and 77.7% in the transobturator-sling group (3.0 percentage-point difference; 95% confidence interval [CI], −3.6 to 9.6). The r...
575 citations